FDA Inspection 809234 — Peravia Industrial, S. A.
The FDA completed an inspection of Peravia Industrial, S. A. on December 4, 2012 in Bani. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 17 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 4, 2012
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Bani (Dominican Republic (the))
Citations
| ID | CFR | Description |
|---|---|---|
| 1426 | 21 CFR 110.20(b)(5) | Adequate lighting |
| 1427 | 21 CFR 110.20(b)(5) | Safety lighting and glass |
| 1473 | 21 CFR 113.83 | Scheduled process - scientific methods not used |
| 1484 | 21 CFR 113.87(a) | Vent not posted |
| 1560 | 21 CFR 110.35(c) | Lack of effective pest exclusion |
| 1581 | 21 CFR 110.37(e) | Running water at suitable temperature |
| 1597 | 21 CFR 110.37(b)(3) | As source of contamination |
| 1651 | 21 CFR 113.40(a)(1) | TID accuracy test frequency |
| 1734 | 21 CFR 113.40(a)(2)(iii) | Adjusted to agree with TID |
| 1735 | 21 CFR 113.40(a)(2)(iii) | Unauthorized adjustment |
| 3658 | 21 CFR 110.37(e)(2) | Hand cleaning and sanitizing preparations |
| 3659 | 21 CFR 110.37(e)(3) | Hand drying |
| 3661 | 21 CFR 110.37(e)(5) | Signs |
| 3877 | 21 CFR 113.60(c) | Coding - required elements |
| 4067 | 21 CFR 113.40(a)(12)(iii) | Venting, other installations |
| 4523 | 21 CFR 108.35(f) | Recall procedures |
| 4529 | 21 CFR 108.35(c)(2)(ii) | Process change reporting to CFSAN |